Nasal Nebulizer for Transporting and Storing Fluids

ABSTRACT

A nasal nebulizer contains a main canister with at least one air exit port and an insert with at least one fluid channel. The fluid channel ends in a common bell housing above a base of the insert, which rests within the canister. The insert and the canister may form one integral unit for single usage, where a cap plugs the air exit port and the fluid channel, allowing for the transport or long-term storage of fluids within the nebulizer device. The insert may include an extension extending out to the canister and a vertical groove may extend down the fluid channel to a hole in the extension, which upon use helps create a vacuum that pulls in deflected fluid for re-use. The nebulizer may also contain a filter surrounding the tube portion near the top of the canister to catch any extraneous matter expelled from the nose during usage.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of and claims filing priorityrights with respect to currently U.S. patent application Ser. No.12/633,269 filed Dec. 8, 2009, which published on Jun. 9, 2011, as U.S.Publication No. 2011/0137290; Ser. No. 12/787,576 filed May 26, 2010,which published on Jun. 9, 2011, as U.S. Publication No. 2011/0132354;and Ser. No. 12/829,198 filed Jul. 1, 2010. U.S. patent application Ser.No. 12/787,576 is, in turn, a continuation-in-part and claims filingpriority rights with respect to U.S. patent application Ser. No.12/633,269. The technical disclosures of all of the above-mentionedapplications are hereby incorporated herein by reference.

TECHNICAL FIELD

The present invention generally relates to devices used foradministering fluid to the upper airway in mist or droplet form, eitherfor the irrigation of the nasal passages or the delivery of medicationin a nasal nebulizer.

BACKGROUND OF THE INVENTION

Devices used for administering liquid medication to a patient by way ofmist or liquid droplets are generally called nebulizers and areprimarily used for the delivery of medication into the lungs. Thesedevices are best suited for the inhalation of the liquid dropletsthrough the patient's mouth. However, some cases require theintroduction of liquid droplets to the patient's nasal passages.

Current nebulizers for introduction of medication to or irrigation ofthe nasal passages contain a reservoir section for filling the deliverydevice with the fluid medication. As the medication is delivered intothe nasal passages, some of the fluid reflects off of the nasalstructures and recollects back into the reservoir container, oftencarrying loosened mucus and other extraneous material with it. It wouldbe desirable to have a nebulizer that allows for the filtering of theextraneous matter expelled together with the expelled fluid. It wouldalso be desirable to have a sanitary disposable nebulizer that allowsfor single usage, which can be disposed of after a first and only use.It is further desirable to have a convenient way of transporting and/orstoring fluids within the nasal nebulizer such that the nebulizer itselfprovides for long term storage of the fluids.

SUMMARY OF THE INVENTION

The present invention generally provides a device for nasal irrigationand drug delivery wherein fluid held in a canister is atomized via acompressed air supply to create particles sized for dispersion andretention within the nasal cavity delivered via a pressurized flow thatis able to stent-open the soft tissues of the nose to deliver theresultant mist into the whole of the nasal passages without the need forthe patient to create an airstream through inhalation. The presentinvention further relates to the long-term storage of the fluid withinthe canister.

A nasal nebulizer device comprises a main canister comprising at leastone air outlet or exit port and a rim surrounding a reservoir forholding fluid; and an insert with a base that fits within the canister,wherein the insert comprises a tube portion ending in a common bellhousing above the base, wherein the base comprises a groove along itsbottom face forming a communication channel between the canister and thecommon bell housing, and wherein the fluid channel is larger in diameterthan the air exit port, thereby providing a small space between theouter surface of the air exit port and the inner surface of the fluidchannel that allows fluid from the reservoir to be drawn through thecommunication channel and between the air exit port and the fluidchannel such that the fluid is expelled as a mist in an aerosol plumethrough an exit hole in the fluid channel due to a venturi effectcreated by pressurized air flow from the air exit port. Thus, whenpressurized air is inserted through an inlet at the bottom of thecanister, a venturi effect is created, and the fluid is drawn from thereservoir and through the fluid channel to be expelled near the air exitport as a mist through an exit hole in the fluid channel. The fluid ofthe canister is atomized and injected directly into the nasal cavity. Insome embodiments, the insert may mate with the canister such that thetwo are rigidly but not necessarily inseparably coupled together.

In a first aspect, the insert and canister of a nasal nebulizer areaffixed or attached to one another to form a single integral structureor piece, thereby providing for a single usage nasal nebulizer. In oneembodiment, the insert is bonded to the canister along the bottom faceof the base of the insert. In another embodiment, the insert is bondedto the canister around a periphery of the base. In another embodiment,the connection may comprise a temporary or mechanical mating between theinsert and the canister. A cap without holes or protrusions extendingtherethrough can be used to cover or plug the exit hole of the fluidchannel and the air exit port in one embodiment, thereby sealing fluidwithin the reservoir until the cap is removed. The cap prevents leakageof the fluid from the reservoir and also allows for long-term storageand delivery of a pre-filled nasal nebulizer that is ready to use.

In a second aspect, the insert comprises an extension protrudingoutwardly from the insert to the canister, forming a top or lid portionto the canister, which mates with a portion of the canister. In oneembodiment, the lid mates with the rim of the canister. The extensionpreferably comprises a downwardly-concave shape relative to its topsurface. The extension further comprises at least one aperture incommunication with the inside of the canister. In one embodiment, theaperture is adjacent to a groove extending vertically along the fluidchannel. The vertical groove directs deflected fluid from the nasalcavity to the concave surface of the extension and the aperture in theextension creates a channel to the canister. Thus, as the mist or fluidvolume exits the canister, a vacuum is created through the aperture,pulling air and any deflected or spent fluid back into the canister.

In a third aspect, the nasal nebulizer comprises a filter that is ableto catch any particulate or extraneous matter that is expelled from thenasal cavity during use.

Other aspects, embodiments and features of the invention will becomeapparent from the following detailed description of the invention whenconsidered in conjunction with the accompanying drawings. Theaccompanying drawings are schematic and not intended to be drawn toscale. In the figures, each identical or substantially similar componentthat is illustrated in various figures is represented by a singlenumeral or notation. For purposes of clarity, not every component islabeled in every figure. Nor is every component of each embodiment ofthe invention shown where illustration is not necessary to allow thoseof ordinary skill in the art to understand the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features believed characteristic of the invention are setforth in the appended claims. The invention itself, however, as well asmode of use and advantages thereof, will best be understood by referenceto the following detailed description of illustrative embodiments whenread in conjunction with the accompanying drawings, wherein:

FIG. 1 is an exploded view of a nasal nebulizer in accordance with anembodiment of the present invention;

FIG. 2 shows a cross sectional view of a canister in accordance with analternate embodiment of the invention;

FIG. 3 shows an alternate embodiment of the cover in accordance with thepresent invention;

FIG. 4 illustrates the use of the nasal nebulizer of FIG. 1 inaccordance with an embodiment of the present invention;

FIG. 5 conceptually illustrates the function of the nasal valve inaerosol delivery that is initiated below the nasal valve;

FIG. 6 shows an embodiment of a nasal irrigator in accordance with anembodiment of the present invention;

FIG. 7 is a schematic cross sectional view of the assembled nasalirrigator of FIG. 6;

FIG. 8 shows a perspective view of an assembled nasal irrigator inaccordance with an embodiment of the present invention;

FIG. 9 a shows an exploded view of an embodiment of a nasal nebulizer inaccordance with an embodiment of the present invention.

FIG. 9 b shows a bottom view of an insert in accordance with anembodiment of the present invention.

FIG. 10 shows a perspective view of an assembled nasal nebulizer inaccordance with an embodiment of the present invention.

FIG. 11 is a schematic cross sectional view of the assembled nasalnebulizer of FIG. 10;

FIG. 12 a shows an exploded view of a nasal nebulizer in accordance withan embodiment of the present invention.

FIG. 12 b shows a bottom view of an insert in accordance with anembodiment of the present invention.

FIG. 13 a shows a top perspective exploded view of the nasal nebulizerof FIG. 12.

FIG. 13 b shows a cross-sectional side view of an assembled nebulizer inaccordance with the present invention;

FIG. 14 shows a perspective view of an assembled nasal nebulizer inaccordance with the present invention;

FIG. 15 shows an exploded view of a nasal nebulizer in accordance withan embodiment of the present invention.

FIG. 16 shows a perspective view of an assembled nasal nebulizer inaccordance with an embodiment of the present invention;

FIG. 17 shows a top view of the nasal nebulizer of FIG. 16.

FIG. 18 shows a schematic cross sectional view of a filter in accordancewith an embodiment of the present invention.

DETAILED DESCRIPTION

The present invention improves upon current nebulizer designs andprovides a method of delivering fluid to the nasal passages with littleinteraction required by the user, under sufficient pressure tostent-open the airway, and with particles of a size to ensure that themajority of the mist is retained or deposited within the upper airway.The invention also provides a nasal nebulizer designed to deliver a mistto the upper airway through both nostrils simultaneously.

In one aspect, a nasal nebulizer of the present invention comprises amain canister with a reservoir for holding fluid, wherein the canisterincludes at least two air exit ports; a removable insert with a circularbase that fits within said main canister, wherein the insert includes atleast two fluid channels that mate with said air exit ports of the maincanister, said fluid channels comprising two tubes ending in a commonbell housing above the base, wherein said base holds the insert just offof the main canister surface, allowing fluid to pass between the baseand main canister, and further wherein the fluid channels are larger indiameter than the air exit ports, thereby providing a small spacebetween the outer surface of the air exit ports and the inner surface ofthe fluid channels that allows fluid from said reservoir to be drawnupward between the air exit ports and fluid channels and expelled as amist in an aerosol plume through exit holes in the fluid channels due toa venturi effect created by pressurized air from the air exit ports; andat least one nozzle coupled to the bottom of said main canister tocreate at least one air chamber defined by the nozzle and said air exitports, wherein the nozzle includes an air inlet for providingpressurized air into said air chamber.

FIG. 1 is an exploded view of a nasal nebulizer in accordance with anembodiment of the present invention. The nasal irrigation devicecomprises three major sections. The first major section is the maincanister 22 which has an expanded reservoir 10 that is capable ofholding up to 50 ml of fluid. The inner portion of the reservoir shapedat the bottom to ensure maximal uptake of fluid to reduce waste.

The main canister 22 also includes an air chamber 11 terminating in twoair exits 12 (one for each nostril) with holes sufficient to deliver anairstream that is able to atomize fluid and stent-open the upper airway.In one embodiment, each exit port 12 has at least one hole of between0.020″ and 0.060″ (0.508 mm-1.524 mm) in diameter and a web-thickness orhole length of between 0.030″ and 0.200″ (0.762 mm-5.08 mm).

On the bottom of the main canister 22 is a foot section 9 that includesone or more feet for stability and an air inlet 8 for the admission ofpressurized air to create the air stream through air exits 12. The footsection 9 enables the canister 22 to stand up when set on a horizontalsurface and is designed to fit into a standard docking port of an aircompressor pump to enable the device to remain upright in a hands-freemanner so as to remain filled with the air supply tube attached.

In the shown example, the main canister 22 has a two-step diameter tofit a holder (not shown) and provide adequate fluid volume for nasalirrigation, with the smaller diameter foot section 9 enabling the userto rest device in the holder with tube attached. In an alternateembodiment (not shown) the foot section 9 is wider than the reservoirsection 10.

The second major section of the nebulizer is the insert 23, which isshown with a base 13 that holds the inside surface of the insert 23 justoff of the outer surface of the feature within reservoir 10 of the maincanister 22. At least one channel is located in the bottom of the insert23 to act as a conduit for fluid from the reservoir 10 to enter the baseof the insert. The insert 23 includes fluid channels 14 that mate withthe air exit ports 12 of the main canister 22. Peaks or extensions maybe included on the air exits 12 to ensure centering of the insert 23 andits fluid channels 14 on the air exits. Similarly, tabs may extend fromthe inside of the fluid channels of the insert to the outer surface ofthe main canister to ensure alignment. As shown, fluid channels 14 ofthe insert 23 comprise two tubes with one end at the bottom of thereservoir 10 and one end that is positioned in the airstream so that theairstream creates a negative pressure in each tube that draws fluid intothe airstream where it is atomized (described below).

In the embodiment shown in FIG. 1, the atomizer outlets 12, 14 extendabove the edge of the main canister 22. However, in an alternateembodiment (not shown) the atomizer nozzles are even with or recessedwithin the edge or portions of the edge of the main canister.

The insert 23 is keyed in at least one location with the reservoir 10 toensure that the insert does not rotate in relation to the exit ports 12of the main canister and to aid in centering of the insert 23 and itsfluid channels 14 on the air exits. The insert may include a feature toensure that it is inserted into the main canister in only oneorientation. In one embodiment, a loop (not shown) extends down to thesaddle of the insert 23 to hold down the insert.

The fluid channels 14 are slightly larger in diameter than the air exitports 12 of the main canister, thereby providing a small space(preferably 0.0001″ to 0.010″ (0.00254-0.254 mm)) between the outersurface of the air exit ports and the inner surface of the fluidchannels. This space allows fluid from the reservoir 10 to proceedupward between the air exit ports 12 and the fluid channels 14 untilbeing expelled by pressurized air. When the insert 23 is installed inthe main canister 22, the orifices of the fluid channels 14 arepositioned relative to the air exits 12 so as to create a venturi effectwith the pressurized gas expelled from the gas tubes. Because the fluidexits 14 in the insert 23 are larger than the air exits 12, when air isforced through the air exits at an appropriate volume and speed, fluidin the reservoir 10 is drawn up into the space between the insert andair exits ports. When this fluid meets the subsequent airstream it isatomized into particles conducive to deposition in the upper airway. Theairstream is sufficient to penetrate the nasal cavity above the inferiorturbinate so as to deposit the fluid and provide a washing, irrigation,or deposition to the upper reaches the nasal cavity.

The exit holes of the fluid channels 14 are small enough to ensure thatmist is created but large enough to ensure that the holes of the insertmay be chamfered so that the walls of the exit holes are angled awayfrom a central axis at an angle that exceeds the cone of the aerosolplume to reduce agglomeration of the mist particles upon exit, providinga more uniform particle size throughout the plume. The fluid channelsize may be adjusted to change the particle size of the mist. In oneembodiment the tubes have a mating section on the upper end that enablesthe changing of the orifice in the air stream via a series of nozzlesthat can be inserted into the upper end of the tubes such that the sizeof the nozzle orifice that is placed into the airstream is varied.

The third major section of the nebulizer is nozzle cone 3. The nozzle 3includes an air inlet 6 and a mating surface 7, which attaches to theair inlet 8 of the main canister 22 to create air chamber 11 defined bythe nozzle and the two exit ports 12 described above. The length of allcomponents on the nozzle cone 3 preferably is limited so that the nozzlecone or its components do not extend past the foot section 9 on the maincanister 22 when the device is assembled to enable the device to beplaced on a flat surface in an upright or standing position.

Ribs may also be molded into the nozzle cone 3 to provide radialstiffness. In another embodiment, the nozzle cone is made of rigidplastic.

The mating surface between the nozzle 3 and main canister 22 is designedto ensure a tight bond can be created. In an alternate embodiment themating surface between the nozzle 3 and main canister 22 is essentiallystraight.

In one embodiment, the nozzle cone 3 is attached permanently to the maincanister 22. In an alternate embodiment, the nozzle cone 3 may utilize afriction fit or have a positive connection such as a thread or othermechanism allowing the nozzle cone and main canister 22 to bedisconnected for cleaning. This detachable embodiment may include an airseal such as an O-ring as well as a flange to grasp for easydisassembly.

An air supply tube 5 connects the air inlet 6 of the nozzle cone with anair supply 17.

FIG. 2 shows a cross section view of a canister 25 in accordance with analternate embodiment of the invention. In this embodiment, rather than asingle air chamber and nozzle, the canister 25 includes separate airpassage chambers 26 that terminate in the air exits 27. These separateair passage chambers 26 can connect to separate air sources via separatenozzles. Alternatively, the separate air passage chambers 26 can beconnected to a common air source via split tubing such as a Y or Tadapter (not shown).

In addition to the three major sections described above, the nebulizermay include a cover 4 which has a mating surface 15 that creates anisodiametric connection to the main canister 22. In the example shown inFIG. 1, the cover 4 is a broad cover region to block space between thenose, eyes and the rest of the face when in use as shown (see FIG. 4).In this embodiment the cover 4 is designed to confine the mist expelledfrom the fluid channels and shield the patient's eyes, with an openingto provide room for the patient's nose within the apparatus. The cover 4is radiused along the distal end away from the main canister 22 to fit abroad variety of faces and is open to enable air to enter as the fluidis drawn down and capture and recycle fluid that falls off the face.

The cover may also incorporate a cross member or other device thatretains the insert 23 to allow for clearance of the nose and preventlifting of the insert at the initiation of atomization. In oneembodiment a sleeve or partial sleeve extends from the cover 4 to thebase of the insert 23 to hold the insert down.

FIG. 3 shows an alternate embodiment of the cover in accordance with thepresent invention. In this embodiment, the cover 28 is a semi-circularlid that does not block the eyes but instead retains the insert andblocks material from re-entering the main canister from the nose.

The present invention may incorporate a feature that guides the user toangle the spray into the nose at a set angle from 0-90 degrees from theplane defined as the front of the face from the chin to the forehead(i.e. the vertical plane of the face). For example, the nebulizer mayinclude a setoff designed to set a specific angle of 30 degrees, 45degrees, or 60 degrees from the vertical plane of the face. The setoffmay be removable for various size faces or noses.

Materials suitable for construction of the nebulizer include rigidplastic, glass, metal, ceramic, carbon fiber or other rigid material, oran elastomer plastic or some combination thereof.

One embodiment of the nasal irrigation device (not shown) is egg-shapedor ovoid for better fit into the hand and a pleasing look.

FIG. 4 illustrates the use of the nasal nebulizer in accordance with thepresent invention. The nebulizer is placed over the face of the user 18and angled such that the cover 4 blocks the eyes. The mist 20 enters thenasal passages 21, and the patient breathes through both the mouth andnose at the same time (24). The mist 20 passes into the nasal passages21 independent of the patient's breathing.

The air-fluid mixture is calibrated to achieve nasal irrigation within ashort period of time, without the need for the fluid to exit thenostrils at the time of irrigation, and with a particle size that isdesigned to loosen the mucous or to enter the sinus cavities, as desiredby the end user and not enter the pharynx or the lungs.

In one aspect, the method of nasal irrigation comprises providing fluidin a canister that includes at least two air exit ports mated tocorresponding fluid channels, wherein the fluid channels are larger indiameter than the air exit ports, thereby providing a small spacebetween the outer surface of the air exit ports and the inner surface ofthe fluid channels. This space allows fluid from said reservoir to bedrawn upward between the air exit ports and fluid channels. Pressurizedair is pumped through the air exit ports, thereby creating a venturieffect that draws fluid from said reservoir upward between the air exitports and fluid channels and expels the fluid as a mist in an aerosolplume through exit holes in the fluid channels and into a user's nasalcavity above the inferior nasal turbinate independent of the user'sbreathing. The pressurized air has a pressure of 0.069-1.035 bar and anairflow rate of 1-12 liters per minute, producing a fluid delivery rateof 1-20 ml per minute.

The method of nasal irrigation offers a fast, convenient method ofatomizing saline or medication for delivery to the nose, with a variableparticle size up to 100 microns. In one embodiment, particle size is atleast 10 microns.

Using an air pressure of 1-15 psi (0.069-1.035 bar) creates apressurized airflow that enables the resultant air-mist stream tostent-open the soft tissues of the upper airway. Optimal performanceappears to occur at 3-12 psi (0.207-0.823 bar), 1-12 lpm of airflow, anda fluid delivery rate of 1-20 ml per minute but will vary according tothe needs of the patient. Typical performance is 4-8 psi (0.276-0.552bar) pressure, 3.5-8 lpm airflow, and 15 ml per minute fluid delivery.

The resultant mist reaches the area of the nasal cavity and paranasalsinuses above the inferior nasal turbinate or chonchae to ensure thatthe mist reaches the areas of the sinus ostia to clear this area of thenasal cavity and enable the natural mucociliary flow to clear thesinuses.

Recent medical research has noted that the olfactory and trigeminalnerves may be used as a pathway to deliver large and small molecules tothe brain and central nervous system that bypasses the blood brainbarrier and first pass metabolism of intravenous and oral deliveryroutes. (See Dhanda, D., Frey W H 2^(nd), Leopold, D., Kompella, U B:“Nose-to-brain delivery approaches for drug deposition in the humanolfactory epithelium.” Drug Delivery Technol. 5(4), 64-72 (2005).) Freyand others have demonstrated that these nerves may be reached via thenasal mucosa overlying the olfactory cleft and cribriform plate wherethese nerves are concentrated. Furthermore, the frequency of dosing ofmany of these materials requires a delivery system that is practical andeasy to use. In the case where systemic delivery of drugs via the noseis desired, maximizing the surface area of the mucosa covered by themedication may improve the amount of medication that is absorbed by thebody and may reduce the variability of absorption between doses andacross patients; thus improving the bioavailability of the drug andreducing the variability of bioavailability of the drug. Furthermore, bymaximizing the surface area available for absorption of any given drug,the concentration required to deliver an effective dose may be reducedwhen compared to traditional metered dose inhaler technology, enablingmore drugs to be delivered transnasally than with other systems.

However, the literature suggests that adequate delivery systems arelacking for the reliable and practical delivery of these substances tothese areas. Delivery of large particles (>10 microns) of liquids in thedescribed volumes as provided by the present invention, offersadvantages over dry powder, minute volumes and high volume solutions.These advantages include covering the whole nasal mucosa, formulatingdrugs for patient comfort vs. concentration, reducing the inadvertentdelivery of aerosolized materials to the lungs; and the ability todeliver precious materials economically and judiciously while reducingwaste.

In one aspect, the present invention provides a method of treatingneoplasms of the nasal cavity comprising fluid in a canister, whereinthe canister includes a reservoir and at least two air exit ports, andwherein said fluid contains corticosteroids. The air exit ports aremated to corresponding fluid channels, wherein the fluid channels arelarger in diameter than the air exit ports, thereby providing a spacebetween the outer surface of the air exit ports and the inner surface ofthe fluid channels, which allows fluid from said reservoir to be drawnupward between the air exit ports and fluid channels. Pressurized air ispumped through the air exit ports, thereby creating a venturi effectthat draws fluid from said reservoir upward between the air exit portsand fluid channels and expels the fluid as a mist in an aerosol plumethrough exit holes in the fluid channels and into a user's nasal cavityabove the inferior nasal turbinate independent of the user's breathing.

The present invention allows for delivering steroids for the long-termcontrol of benign neoplasms of the nasal cavity, such as inflammatorynasal polyps, granulomas, etc., without systemic doses of steroids orsteroid injections. It also provides the ability to irrigate the wholenasal mucosa to manage the disruption of natural filtering andhumidification often caused by ablative and reconstructive surgicaltreatment of neoplasms. Unlike prior art saline irrigation and nasalsprays which do not reach many of the areas of concern in the nasalvestibule and paranasal sinus areas, the nebulizer of the presentinvention delivers adequate moisture in less than one minute to theareas of concern. The present invention also avoids pooling of moisturethat can otherwise provide a nidus for infection and cause excessiveremoval of the immunologic mucus blanket of the nose.

The high frequency of steroid administration needed to control neoplasmgrowth requires a delivery system that is practical and easy to use. Thenebulizer of the present invention can deliver these steroids quickly—inless than one minute—covering the whole nasal cavity and does so withoutunduly exposing the body to the effects of systemic steroids.

For example, using the nebulizer of the present invention, 0.60 mgs ofcorticosteroid is typically delivered to the nasal cavity, between twoand ten times the amount delivered via metered dose inhalers. In someinstances, antibiotics are delivered along with the corticosteroid totreat infections such as Staphylococcus aureus. Staph Aureus endotoxinhas been shown to up-regulate the beta isoform of cortisol receptor(CR_(β)) in cell membranes that is responsible for inhibiting theresponse to corticosteroids, and it is believed that the Staph infectionmay contribute to steroid-resistant nasal polyps. The concurrentadministration of antibiotics with the corticosteroid via the nebulizerof the present invention reduces this endotoxin effect on the cortisolreceptor, thereby increasing the efficacy of the steroid therapy.

The pressure and airflow necessary to deliver material to the upperportion of the nose can be reduced if the aerosol is introduced distalof the nares at or above the nasal valve and proximal to the inferiorturbinate. The present invention delivers droplets or mists with an airstream and particle sizes designed to stay in the upper airway undersufficient pressure and airflow to overcome the normal aerodynamics ofthe nose. Unlike prior art methods, the present invention releases mistat or above the nasal valve, thereby avoiding deflection of the fluidoff the walls of the nostril and nasal valve.

Effective delivery of material to the nasal cavity requires a particlesize that is large enough to fall out of the airway before reaching theoropharynx, delivered under sufficient pressure and airflow to overcomethe aerodynamics of the nasal cavity. The nasal cavity is shaped toefficiently deliver air to the lungs. Air enters the nares and passesthrough the nasal valve, which resides approximately 1.3 cm above thenares and is the narrowest portion of the nose, with a cross-section ofat approximately 0.73 cm². The nasal valve is the narrowest anatomicportion of the upper airway, resulting in the volume of air inspirednasally to be efficiently cleansed and humidified by the nasal cavity.

FIG. 5 conceptually illustrates the function of the nasal valve inaerosol delivery that is initiated below the nasal valve. Arrows 120represent an aerosol flowing into the nasal nares. As illustrated byarrows 121, a portion of this aerosol is reflected off the walls of thenose as the passageway narrows to the nasal valve 130. This reflectedmaterial falls out of the nose and is either wasted or is recollected bythe device to be delivered repeatedly.

The nasal valve 130 acts to reduce the flow (F) and pressure (P) of thatportion of the aerosol stream that crosses the valve and enters thenasal cavity 110. Thus, Flow in (F_(I)) is greater than Flow out(F_(O)), and Pressure in (P_(I)) is greater than Pressure out (P_(O)).As a result, aerosol entering the nasal cavity external to the nasalvalve requires a higher pressure and flow rate to achieve the sameaerosol distribution as an aerosol introduced internal to the nasalvalve.

Air entering the nose meets additional resistance at the level of theinferior turbinate, which directs air downward along the floor of thenose along the path of least resistance. During inhalation, the airflowis dominated by the negative pressure being generated from the lowerairway and is directed to the nose from the pharynx. This negativepressure and the structure of the nasal cavity conspire to direct themajority of the air through the lower third of the nose, with verylittle air entering the upper portion of the nose. Indeed, studies haveshown that to reach the upper portion of the nose under the negativepressure of normal breathing, an aerosol must be placed very preciselyat the front of the nares. To overcome the aerodynamics of the nose, thedelivery system must provide a positive pressure and sufficient airflowto fill the whole nasal cavity.

Prior art devices that deliver aerosol below the nasal valve mustgenerate higher pressure and flow rates since the valve acts to lowerthe pressure and flow as the aerosol passes through it. The design ofthe present invention is directed to the self-administration of fluid tothe nasal passages of a patient while ensuring the device fits a widevariety of faces and for simplicity of design, ease of manufacturer. Itrequires lower pressure and airflow and produces less mess by virtue ofdelivery above the nasal valve, and simplicity of use, including shortdelivery times.

The invention delivers fluid to the nasal passages with littleinteraction required by the user and under sufficient pressure tostent-open the airway. The invention delivers particles of a size toensure that the majority of the mist is retained or deposited within theupper airway, while maximizing the amount of drug delivered andeliminating reflection back from the nasal valve.

FIG. 6 shows an embodiment of a nasal irrigator in accordance with thepresent invention. The nasal irrigator comprises three main components.The first component is the main canister 201, which has a fluidreservoir 202 and an air exit port 203 that extends above the reservoir.In one embodiment, the reservoir 202 holds up to 30 ml of fluid ormedication. As shown in FIG. 1, the lower portion of the reservoir isdownward sloping to ensure fluid collects at the bottom, which allowsmaximal uptake of fluid through fluid channels (explained below),thereby minimizing waste.

The air exit port 203 has at least one exit hole 204 at the topsufficient to deliver an airstream that is able to atomize fluid anddeliver the aerosol to the whole nasal cavity. In one embodiment, theexit hole 204 is between 0.020″ (0.508 mm) and 0.060″ (1.524 mm) indiameter and the air exit port has a web-thickness of between 0.030″ and0.200″ (0.762 mm-5.08 mm).

The main canister 201 also included an air inlet 205 on the bottom forthe admission of pressurized air to create the air stream exiting theair exit port 203.

In one embodiment, the main canister 201 has optional “feet” on thebottom (as shown in FIG. 1) for stability. The length of all componentson the nozzle cone is limited so that the nozzle cone or its componentsdo not extend past the feet on the main canister when the device isassembled to enable the device to be placed on a flat surface in anupright or standing position. The canister 201 may also be designed tofit into a standard docking port of an air compressor to enable thedevice to remain upright in a hands-free situation so as to be filledwith the air supply tube attached.

The second main component of the nasal irrigator is an insert 206 thatfits over the main canister's air exit port 203. The insert 206 can bepermanently attached to the canister 201 or it may be removable. Theinsert 206 has an aerosol exit 210 that is concentrically aligned withthe exit hole 204 of the air outlet 203. A peak or extension on the airexit port 203 may ensure centering of the insert over the air outlet.Similarly, tabs on the insert may be used to center the insert over theair outlet and prevent it from being moved by force. The aerosol exit210 is slightly larger than the exit hole 204 of the air exit port 203to enable atomization of fluid in the air stream.

The insert 206 has a tapered inner diameter 207 that is larger than andfollows the contours of the outer diameter 208 of the air exit port 203.This difference in diameter creates a space of between 0.0001″ (0.00254mm) and 0.010″ (0.254 mm) between the inner surface of the insert 206and the outer surface of the air exit port 203. This space allows fluidto be drawn from the reservoir 202 through a channel 209 at the basethat is sized to control the fluid flow.

The third main component of the nasal irrigator is the cover 211 thatmates with the reservoir 202 of the main canister 201 and extends overthe insert 206 such that the insert does not contact the nose as thedevice is inserted into the nasal cavity, thereby ensuring that the hole210 in the insert 206 and the hole 204 in the air exit port 203 remainconcentrically aligned. The cover 211 includes a mating surface 212 thatcreates a preferably isodiametric connection to the main canister 201and extends around the nozzle formed by the insert 206 and air exit port203. The cover 211 extends just above the insert 206 and has its ownexit hole 214 designed not to restrict the flow of the aerosol plume. Inone embodiment, the cover 211 provides a cross member or other featurethat secures the insert 206 to prevent lifting of the insert at theinitiation of atomization.

FIG. 7 is a schematic cross section view of the assembled nasalirrigator in accordance with the present invention. This view shows thealignment of the canister 201, insert 206, and cover 211 and theresulting fluid space 215. When fluid is in the reservoir 202 and apressurized air source is introduced to the system via air inlet 205, avacuum is created in the space 215 as air exits through outlets 204 and210. Because the aerosol exit hole 210 in the insert 206 is larger thanthe exit hole 204 of the air exit port 203, when air is forced throughthe air exit port 203 at an appropriate volume and speed it creates aventuri effect as the pressurized gas is expelled, thereby drawing fluidin the reservoir 202 up into the space 215 between the insert and airoutlet. When the fluid reaches the airstream between the exit holes 204,210, it is atomized in the airstream to create an aerosol. This aerosolis sufficiently dispersed within the nasal cavity above the inferiorturbinate so as to the reach the upper nasal cavity.

The aerosol exit 210 in the insert 206 is small enough to ensure that amist is created yet large enough to ensure that the hole can bechamfered on the outer side to reduce agglomeration of the mistparticles upon exit. The aerosol exit hole 210 is chamfered so that thewalls of the exit are angled away from a central axis of the hole suchthat the angle is greater than that of the aerosol plume. Thischamfering reduces agglomeration of particles on the walls of theaerosol exit hole 210, resulting in uniformity of particle size acrossthe resultant aerosol plume.

The base of the insert 206 sits in a groove 217 at the base of thecanister 201, ensuring that all fluid is drawn from the bottom of thecanister.

The nebulizer components of the present invention can be made frommaterials such as rigid plastic, glass, metal, ceramic, carbon fiber orother rigid material, an elastomer plastic, or some combination thereof.

FIG. 8 shows a perspective view of an assembled nasal irrigator inaccordance with the present invention. By maintaining a sufficientlynarrow nozzle assembly 218, and a sufficiently long and smooth cover219, the device can be easily and atraumatically inserted into the noseof the patient so that the nozzle 218 extends to or above the nasalvalve. The device is then angled by the user to obtain the bestdistribution based on the user's anatomy. The mist enters the nasalcavity independent of the patient's breathing.

The nasal irrigator of the present invention may also include a featurethat guides the user to angle the spray into the nose to a set angle ofbetween 0 and 90 degrees from the vertical plane of the face (defined asthe front of the face from the chin to the forehead). For example, oneembodiment of the nasal irrigator includes a setoff that sets a specificangle of 30 degrees from the vertical plane of the face. In anotherembodiment, the setoff angle is 60 degrees from vertical, and in anotherembodiment the setoff angle is 45 degrees from vertical. The setoffdescribed above is removable to accommodate various size faces andnoses.

The method of nasal irrigation of the present invention uses a variableparticle size up to 100 microns under a pressure of 1-15 psi(0.069-1.0345 bar), creating a pressurized airflow that enables theresultant air-mist stream to reach the whole nasal cavity independent ofthe patient's breathing. The resultant aerosol mist reaches the area ofthe nasal cavity above the inferior nasal turbinate or chonchae toensure that the mist reaches the areas of the sinus ostia to clear thisarea of the nasal cavity and enable the natural mucociliary flow toclear the sinuses.

By adjusting the size of the exit holes 204 and 210, the air-fluidmixture can be calibrated to achieve nasal irrigation within a shortperiod of time, without the need for the fluid to exit the nostrils atthe time of irrigation, and with a particle size that is designed toloosen the mucous or to enter the sinus cavities, as desired by the enduser. In many applications, ideally a mist of 20 microns is delivered ata rate of 0.5 ml per second.

The aerosol mist itself is typically medicated with at least one, andoften two or more therapeutic agents. Possible therapeutic agents foruse in the medicated mist, either alone or in combination includeantibiotics, antifungal agents, corticosteroids and mucolytic agents.The mist may also be medicated with a neurologically-active agenttargeting the central nervous system through the cranial nervesinnervating at least a portion of the nasal cavity as well assystemically-active agents.

FIG. 9 a is an exploded view of an improved nasal nebulizer deviceaccording to one embodiment of the present invention. The devicecomprises a main canister 220, an insert 221, and a cap 223. The maincanister 220 and the insert 221 comprise many of the samecharacteristics of the nebulizer described with relation to FIG. 1. Themain canister 220 comprises a rim surrounding a reservoir 227, which canhold up to 50 mL of fluid. While the reservoir is depicted assubstantially circular, it should be appreciated that the reservoir maycomprise any shape. In one embodiment, the reservoir comprises an ovalshape. As previously described with respect to FIG. 1, the main canister220 also comprises an air chamber that terminates into at least one airexit port 228. In one embodiment, as depicted in FIGS. 9-11, the airchamber of the canister terminates into two air exits ports 228 (one foreach nostril). In another embodiment, as best depicted in FIGS. 12-14,the air chamber of the canister terminates into only one single air exitport.

As described above with respect to FIG. 1, each air exit port 228 has atleast one hole of between 0.020″ and 0.060″ (0.508 mm-1.524 mm) indiameter and a web-thickness or hole length of between 0.030″ and 0.200″(0.762 mm-5.08 mm). In addition, as with the embodiment of FIG. 1, onthe bottom of the main canister 220 is a foot section 224 that includesat least one foot for stability and an air inlet (as depicted in FIG.11) for the admission of pressurized air to create the air streamthrough air exit ports 228. The foot section 224 enables the canister220 to remain standing on its own when set on a substantially horizontalsurface and is designed to fit into a standard docking port of an aircompressor pump to enable the device to remain upright in a hands-freemanner so as to remain filled with the air supply tube attached.

The insert 221 comprises a base 229 that fits within the canister 220and sits just off the bottom of the reservoir 227. In one embodiment, asdepicted in FIG. 9, the base 229 is circular. However, the base maycomprise any number of shapes so long as it fits within the canister.The insert 221 further comprises a fluid channel 225 that fits over theair exit port 228, said fluid channel 225 comprising a tube portionending in a common bell housing 234 above the base. In one embodiment,the insert comprises two fluid channels. In another embodiment,described below, the insert comprises one fluid channel.

As best depicted in FIG. 9 b, the bottom face of the base 229 of theinsert 221 comprises at least one groove 226 that forms a communicationchannel between the canister and the common bell housing of the insert.The groove 226 extends from the outside of the base to the inside of theinsert. The base should comprise at least one groove but may alsocomprise more than one, as depicted in FIG. 9 b. The number of groovesas well as the width and depth of the groove will help regulate the flowof fluid up to the point that the airflow takes over the upper limit offlow. In one embodiment, the grooves may range in width from about0.005″ to about 0.150″ (0.127 mm to about 3.81 mm). In one embodiment,the grooves may range in depth from about 0.001″ to about 0.050″ (0.0254to about 1.27 mm). The fluid channel 225 is larger in diameter than theair exit port 228, thereby providing a small space between the outersurface of the air exit port 228 and the inner surface of the fluidchannel 225 that allows fluid from said reservoir 227 to be drawnthrough the communication channel and upward between the air exit port228 and the fluid channel 225 such that the fluid is expelled as a mistin an aerosol plume through an exit hole 230 in the fluid channel due toa venturi effect created by the introduction of pressurized air from theair exit port.

In one aspect, the canister 220 and the insert 221 are preferablyaffixed together such that the insert 221 and the canister 220 togetherform an integral piece. As used herein, “affix” relates to a secureattachment between the canister and insert and may include bothpermanent bonding and temporary bonding, which may only be subsequentlymanually separated. Preferably, the affixing of the insert and canisterwill not interfere with or negatively affect the communicationchannel(s) formed by the grooves in the bottom face of the insert. Inone embodiment, the insert 221 is permanently affixed or bonded to thecanister 220 at the bottom face of the insert. The bond may be formed byany means known in the art including without limitation use of a solventbond, glue UV-cured adhesives, mechanical attachment, heat forming, orradiofrequency or ultrasonic welding. In another embodiment, thecanister 220 and the insert 221 may mechanically mate together, such aswith a friction fit or a snap fit, to form a temporary connectionbetween them that can be subsequently separated by the user as desired.

In yet another embodiment, where the insert comprises two fluidchannels, the nasal nebulizer may further comprise a cross bar component222 having an edge that fits around the rim of the canister. Thecrossbar component may comprise a single crossbar 232 that extends fromone edge of the component 222 to another edge, dividing the component222 into two substantially equal halves, as depicted in FIG. 9 a forexample; or it may comprise a crossbar that extends from one edge to oneor more other edges at a different locations around the circumference,dividing the enclosed space into multiple areas. In such embodiments,the crossbar component 222 may be permanently affixed or bonded to therim of the canister 220, thereby affixing the insert 221 to the canister220. The bond may be formed by any means known in the art includingwithout limitation use of a solvent bond, glue UV-cured adhesives,mechanical attachment, heat forming, or radiofrequency or ultrasonicwelding.

Covering the canister 220, insert 221, and optional crossbar component222 is a cap 223 without holes therethrough. As depicted in FIG. 10, acap 223 fits over the rim of the canister 220 and covers the tubeportion of the insert, plugging the exit hole 230 of the fluid channel225 and the air exit port 228 to form an airtight, hermetic seal for thenebulizer device, preventing the leakage of the fluid from thereservoir. The cap may further comprise an alignment feature or thumbhold 231 along its outer edge, which may align with a similar alignmentfeature or thumb hold on the exterior of the canister 220. Thus, thenebulizer in one embodiment allows for sterile or non-sterile drugstorage and serves as a carrier for the transport or shipment ofmedication or irrigation fluid.

FIG. 11 is a cross sectional view of an assembled nasal nebulizercomprising a canister 220, insert 221, optional crossbar component, andcap 223. As best shown here in FIG. 11, the cap 223 may comprise sealingplugs 233 recessed within the cap, which extend through both the exithole 230 of the fluid channel 225 and the air exit port 228. In oneembodiment, the sealing plugs 233 may be comprised of an expandablematerial, which will expand once removed from the top of the nebulizerdevice. In another embodiment, the cap may be threaded and include agasket to form a compression seal. When ready for use, a user can removethe cap and connect an air supply to the air inlet beneath thereservoir.

A method of forming a disposable nasal nebulizer in comprises the stepsof providing a canister 220 with an air exit port 228 and a rimsurrounding a reservoir 227 for holding fluid; providing an insert 221with a base 229 that fits within the canister 220, the insert 221comprising a fluid channel 225 that fits over the air exit port 228,said fluid channel comprising a tube portion ending in a common bellhousing 234 above the base, said base comprising at least one groove 226along its bottom face forming a communication channel between thereservoir 227 of the canister 220 and the common bell housing 234,wherein the fluid channel 225 is larger in diameter than the air exitport 228, thereby providing a small space between the outer surface ofthe air exit port 228 and the inner surface of the fluid channel 225that allows fluid from said reservoir 227 to be drawn through thecommunication channel and upward between the air exit port 228 and fluidchannel 225; and affixing the canister 220 together with the insert 221,thereby forming one integral structure.

The providing steps (a) and (b) can comprise the step of manufacturingthe canister or the insert, or both the canister and the insert. Themanufacturing can be performed by any means known in the art includingwithout limitation molding, forming, shaping or any combination thereof.The providing step (a) may also comprise the step of obtaining thecanister from any manufacturer or vendor, for example. Similarly, theproviding step (b) may comprise the step of obtaining the insert fromany manufacturer or vendor. By way of example, in one embodiment, theinsert may be permanently attached to the canister along its base 229.Preferably, the bond would be formed such that the groove 226 remains acommunication channel. Thus, the bonding should not substantially blockor plug the groove 226. In one embodiment, the insert is bonded orpermanently attached along its bottom face to an interior side of thecanister. A suitable solvent bond includes, for example, any plasticadhesive including without limitation ABS, acrylic, polystyrene, andpolycarbonate solvents such as cyclohexanone. With the insert andcanister forming one integral structure, fluid may be inserted into thereservoir 227 and the cap 223 can be placed over the rim of the canisterto seal the fluid within the nebulizer device for transport or shipment.

FIG. 12 a depicts an exploded view of another embodiment of a nasalnebulizer. Similar to the above devices, the nasal nebulizer comprises amain canister 240 with an air exit port 245 and a rim 243 surrounding areservoir 247 for holding fluid. The air exit port 245 extends beyondthe rim 243 of the canister and has at least one exit hole at the topsufficient to deliver an airstream that is able to atomize fluid anddeliver an aerosol. The main canister may also comprise the foot section246 for stability. In addition, if desired, the canister may compriseone or more horizontal marks or lines to indicate specific fluid levels.

FIG. 12 b depicts an embodiment of the insert 241 with a base 248 thatfits within the main canister 240, wherein the insert has a bottom facewith at least one groove 244 to form a communication channel between thecanister 240 and the common bell housing 249. In one embodiment, asdepicted in FIG. 12 b, the groove at the bottom of the insert 241 mayextend from the outside edge of the bottom face to a peripheral groovesurrounding the opening of the common bell housing. The insert furthercomprises an extension 250. As depicted in FIGS. 12 a and 13 a, in oneembodiment, the extension 250 protrudes outwardly from the mid-sectionof the insert 241 above the common bell housing 249. In otherembodiments, however, the extension may also extend from another pointalong the insert, from the common bell housing to any point closer tothe exit 253 of the fluid channel. The extension 250 forms a top, orlid, to the canister 240 that mates with the rim 243 of the canister. Inone embodiment, the extension comprises a downward concave shaperelative to a plane substantially perpendicular to the fluid channel;or, relative to the top surface of the lid. In one embodiment, theextension comprises a two-step diameter 257 to mate with the rim 243.The insert 241 further comprises one or more apertures 251 around thefluid channel, each of the apertures lining up with a vertical groove252 along the exterior of the fluid channel 262. The groove 252 runsvertically from a point below the exit hole of the fluid channel 253down to an aperture 251 in the extension 250. During use, the deflectedfluid will begin to flow back down the vertical groove 252. The aperture251 communicates with the inner chamber formed by the mating of the maincanister 240 and insert 241. As fluid exits the inner reservoir, avacuum is created that actually pulls the deflected fluid back into thereservoir 247 through the aperture 251, thereby ensuring maximum usageand minimized waste of the fluid.

The nebulizer further comprises a cap 242 without holes that fits overand inserts into the fluid channel 253 and the air exit port 245 to sealthe reservoir from the air exit and fluid exit. The cap comprises anelongated portion 256 to ensure a good fit over the tube portion.Optionally, the cap may comprise a flattened edge 255 to help withalignment with the apertures 251 of the insert 242 and also help withthe grasping the cap 242. The bottom portion 258 of the cap mates with aportion of the top face of the extension. Thus, as best depicted in FIG.12 a, the bottom face of the cap 242 is relatively upwardly convex inone embodiment to mate with the downwardly concave extension 250. Thecap 242 further comprises one or more projections 254 on its bottomface, which mates with the apertures 251 of the extension. Inparticular, the projection 254 aligns with and seals the aperture 251when the cap 242 is placed over the insert 241, as best shown in FIG.14. Thus, the number of projections 254 on the bottom face of the cap242 should equal the number of apertures 251 in the insert 250. As bestdepicted in FIG. 13 b, the cap further comprises a sealing plug 259 thatprojects into and fits within the exit hole of the fluid channel 253 inthe insert 241 and the air exit port 245, thereby sealing the nasalnebulizer.

Similar to the embodiments described above with regard to FIGS. 9-11, inorder to make a disposable device in accordance with one aspect of thepresent invention, the canister 240 and the insert 241 are affixedtogether such that the insert 241 and the canister 240 together form anintegral or single piece. In embodiments comprising an extension 250extending from the insert to the rim of the canister (as depicted inFIGS. 12-13), the extension may form a top that mates with the rim ofthe canister and the edges of the extension may be permanently affixedto the rim of the canister. Thus, in one embodiment, it is the extensionthat is permanently affixed to the rim of the canister by way ofbonding, for example. In another embodiment, the extension may form atop that mates together with a portion of the canister. A suitablesolvent bond includes, for example, any plastic adhesive includingwithout limitation ABS, acrylic, polyacetal, polyethylene, polyester,polypropylene, polystyrene, or polycarbonate solvent, UV-cured adhesive,heat or ultrasonic welding or over molding of materials. Bonding withsuch materials can be performed by any means known in the art. Havingthe insert and canister as a single integral piece, fluid may beinserted into the reservoir 247 and the cap 242 can be placed over theexit hole 253 and the aperture(s) 251 of the insert 241 to seal thefluid within the nebulizer device for transport or shipment. The capsits over the tube portion of the fluid channel and the fluid within thereservoir remains sealed within the nebulizer device until ready foruse. FIG. 14 depicts an assembled, sealed device 260 ready fortransport.

As with the above embodiments, the orifices of the fluid channels shouldbe positioned relative to the air exits so as to create a venturi effectwith the pressurized gas expelled from the gas tubes. Thus, the affixingstep should account for this positioning. Because the fluid channelexits in the insert are larger than the air exits, when air is forcedthrough the air exits at an appropriate volume and speed, fluid in thereservoir is drawn up into the space between the insert and air exitsports. When this fluid meets the subsequent airstream it is atomizedinto particles conducive to deposition in the upper airway.

FIG. 15 is an exploded view of an embodiment of a nasal nebulizer devicecomprising a canister section 270, an insert 271, and a filter 272.Similar to the above devices, the canister section 270 comprises acanister 273 with reservoir 275 and an air exit port 276 having an exithole 277. The canister section 270 also comprises one or more feet 274beneath the canister 273; and the insert 271 comprises a base 278 thatfits within the reservoir of the canister and at least one fluid channel280 with an exit hole 281. As described above, the insert and canistersection once formed, shaped, molded or obtained, are affixed to oneanother.

In one embodiment, the nasal nebulizer device further comprises a filtercomponent 272 that may be inserted over the insert 271. The filtercomponent 272 comprises a filter 284 comprised of a mesh structure withholes small enough to prevent any particulate matter or mucus that runsout of the nose from entering the reservoir 275, while allowing theirrigating or medicating fluid to run back into the reservoir 275 to bere-circulated or re-used. Suitable materials from which to create thefilter are plastic, metal, carbon fiber, or other fiber. In embodimentscomprising more than one fluid channel, the filter component alsocomprises a crossbar component 283. In one embodiment, the crossbar 283is an integral part of the filter component 272. However, it should beunderstood that the crossbar 283 could also form a separate component,which is detached from the filter, and remains optional.

FIG. 16 is a perspective view of an assembled nebulizer having an inserthaving two fluid channels 280 and a filter 284 with the optionalcrossbar 283, wherein the insert is affixed to the canister to form onesingle integral structure. As described above, in one embodiment, theinsert is affixed to the canister by way of bonding. The bonding maycomprise the joining of the bottom face of the insert base to thecanister or the joining of the periphery of the base to the canister. Inone embodiment, the insert may be affixed to the canister by permanentlybonding the periphery 282 of the filter to the rim of the insert. Asbest depicted in FIG. 17, the filter 284 surrounds the tube portion 280of the insert and extends from the rim of the canister to the tubeportion 280, substantially covering the opening of the canister suchthat when in use, the filter prevents particulate matter from enteringthe reservoir.

With reference to FIGS. 12 and 13, where the nasal nebulizer comprisesan extension, in one embodiment, a filter entirely covers or fits withinthe apertures 251 in the extension 250 to similarly keep particularmatter out of the reservoir and separate from the fluid forre-circulation. The filter may slide over the fluid channel of 241 ormay be bonded over or under the apertures 251 or even molded into theInsert 241.

The invention illustratively disclosed herein suitably may be practicedin the absence of any element, which is not specifically disclosedherein. It should also be notes that the invention is not limited tohuman use, but may also be used with any number of mammals includingwithout limitation equine, canine, feline, non-human primate, rodent,bovine, and porcine.

The description of the present invention has been presented for purposesof illustration and description, and is not intended to be exhaustive orlimited to the invention in the form disclosed. Many modifications andvariations will be apparent to those of ordinary skill in the art. Theembodiment was chosen and described in order to best explain theprinciples of the invention, the practical application, and to enableothers of ordinary skill in the art to understand the invention forvarious embodiments with various modifications as are suited to theparticular use contemplated. It will be understood by one of ordinaryskill in the art that numerous variations will be possible to thedisclosed embodiments without going outside the scope of the inventionas disclosed in the claims.

1. A nasal nebulizer, comprising: (a) a main canister comprising atleast one exit port and a rim surrounding a reservoir for holding fluid;and (b) an insert with a base that fits within the canister, wherein theinsert comprises at least one fluid channel that fits over the air exitport, said fluid channel comprising a tube portion ending in a commonbell housing above the base, wherein said base comprises at least onegroove along its bottom face forming a communication channel between thecanister and the common bell housing, and further wherein the fluidchannel is larger in diameter than the air exit port, thereby providinga small space between the outer surface of the air exit port and theinner surface of the fluid channel that allows fluid from said reservoirto be drawn through the communication channel and upward between the airexit port and fluid channel such that the fluid is expelled as a mist inan aerosol plume through an exit hole in the fluid channel due to aventuri effect created by pressurized air from the air exit port;wherein the insert is affixed to said canister such that the insert andthe canister together form an integral structure.
 2. The nasal nebulizerof claim 1 comprising a cap without holes therethrough thatsubstantially covers the tube portion of the insert, said cap pluggingthe exit hole of the fluid channel and the exit port and forming anairtight seal for the nebulizer, thereby preventing the leakage of thefluid from the reservoir.
 3. The nasal nebulizer of claim 1 wherein theinsert is permanently affixed to the canister.
 4. The nasal nebulizer ofclaim 1 wherein the insert is temporarily secured to the canister. 5.The nasal nebulizer of claim 3 wherein the bottom face of the base ofthe insert is bonded to the inside of the canister.
 6. The nasalnebulizer of claim 3 wherein the periphery of the base of the insert isbonded to the inside of the canister.
 7. The nasal nebulizer of claim 3further comprising a crossbar component with a periphery surrounding therim of the canister, wherein said periphery is bonded to said rim. 8.The nasal nebulizer of claim 1 wherein the insert comprises an extensionprotruding outwardly to the rim of the canister, said extension forminga lid that mates with a portion of the canister.
 9. The nasal nebulizerof claim 8 wherein the fluid channel comprises a groove extendingvertically along the fluid channel to an aperture in the extension, saidaperture creating a channel to the canister that allows for a vacuum topull in air and deflected fluid into the canister as the mist exits. 10.The nasal nebulizer of claim 8 comprising a cap without holestherethrough, said cap comprising a sealing plug for sealing the airexit port and the fluid channel of the insert and comprising furtherwherein said cap comprises a projection that fits within the aperture ofthe extension, thereby sealing the aperture.
 11. The nasal nebulizer ofclaim 8 wherein the lid comprises a downwardly concave shape.
 12. Thenasal nebulizer of claim 4 wherein the extension comprises a two-stepcircumference.
 13. The nasal nebulizer of claim 1, comprising a filtersurrounding the tube portion of the insert.
 14. The nasal nebulizer ofclaim 9, wherein said aperture comprises a filter comprised of a meshstructure.
 15. A method of forming a disposable nasal nebulizer, saidmethod comprising the steps of: (a) providing a canister with an airexit port and a rim surrounding a reservoir for holding fluid; (b)providing an insert with a base that fits within the canister, saidinsert comprising a fluid channel that fits over the air exit port, saidfluid channel comprising a tube portion ending in a common bell housingabove the base, said base comprising a groove along its bottom faceforming a communication channel between the canister and the common bellhousing, wherein the fluid channel is larger in diameter than the airexit port, thereby providing a small space between the outer surface ofthe air exit port and the inner surface of the fluid channel that allowsfluid from said reservoir to be drawn through the communication channeland upward between the air exit port and fluid channel; (c) affixing thecanister together with the insert, thereby forming one integralstructure; and (d) plugging the air exit port and the fluid channel witha cap.
 16. The method of claim 15 wherein the providing step a)comprises at least one of the following: molding, forming, shaping orobtaining the canister.
 17. The method of claim 15 wherein the providingstep b) comprises at least one of the following: molding, forming,shaping or obtaining the insert.
 18. The method of claim 15 wherein thecap mates with a portion of the canister.
 19. The method of claim 15wherein the cap mates with an extension of the insert, said extensionprotruding outwardly from the insert to a portion of the canister. 20.The method of claim 15 wherein said plugging comprises a sealing plugrecessed within the cap, and further wherein said cap substantiallycovers the fluid channel.
 21. The method of claim 19 wherein saidextension comprises at least one aperture extending through to thereservoir, and said cap comprises at least one projection that seals theaperture, said method further comprising the steps of: introducingpressurized air through an inlet at the bottom of the canister, therebycreating a venturi effect and expelling the fluid as a mist through anexit hole in the fluid channel; and creating a vacuum as the mist exits,said vacuum pulling in air and deflected fluid through the aperture intothe canister.
 22. A nasal nebulizer comprising: (a) a main canistercomprising an exit port and a rim surrounding a reservoir for holdingfluid; (b) an insert with a base that fits within the canister, whereinthe insert comprises a fluid channel that fits over the air exit port,said fluid channel comprising a tube portion ending in a common bellhousing above the base, wherein said base comprises a groove along itsbottom face forming a communication channel between the canister and thecommon bell housing, and further wherein the fluid channel is larger indiameter than the air exit port, thereby providing a small space betweenthe outer surface of the air exit port and the inner surface of thefluid channel that allows fluid from said reservoir to be drawn throughthe communication channel and upward between the air exit port and fluidchannel such that the fluid is expelled as a mist in an aerosol plumethrough an exit hole in the fluid channel due to a venturi effectcreated by pressurized air flow from the air exit port; and (c) a filtersubstantially surrounding the tube portion of the insert, wherein saidfilter rests against the rim of the canister.
 23. A nasal nebulizercomprising: (a) a main canister comprising an exit port and a rimsurrounding a reservoir for holding fluid; (b) an insert with a basethat fits within the canister, wherein the insert comprises a fluidchannel that fits over the air exit port, said fluid channel comprisinga tube portion ending in a common bell housing above the base, whereinsaid base comprises a groove along its bottom face forming acommunication channel between the canister and the common bell housing,and further wherein the fluid channel is larger in diameter than the airexit port, thereby providing a small space between the outer surface ofthe air exit port and the inner surface of the fluid channel that allowsfluid from said reservoir to be drawn through the communication channeland upward between the air exit port and fluid channel such that thefluid is expelled as a mist in an aerosol plume through an exit hole inthe fluid channel due to a venturi effect created by pressurized airflow from the air exit port; and (c) an extension protruding outwardlyto a portion of the canister, said extension forming a lid for thecanister.
 24. The nasal nebulizer of claim 23 wherein said extensionmates with a portion of the canister.
 25. The nasal nebulizer of claim23 wherein said extension comprises at least one aperture, said aperturecreating a channel to the canister that allows for a vacuum to pull inair and deflected fluid into the canister as the mist exits.
 26. Thenasal nebulizer of claim 23 wherein the fluid channel comprises a grooveextending vertically along the fluid channel.
 27. The nasal nebulizer ofclaim 23 wherein the lid forms a downwardly concave shape.